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provided by Repositori d'Objectes Digitals per a l'Ensenyament la Recerca i la Cultura Espí-López GV, Oliva-Pascual-Vaca A. Eur J Ost Clin Rel Res. 2012;7(1):10-21.

ORIGINAL ARTICLE

Atlanto-Occipital Manipulation and Suboccipital Inhibition Technique in the Osteopathic Treatment of Patients with Tension-Type Headache

Espí-López GV * a (PT, PhD), Oliva-Pascual-Vaca A b,c (PT, DO, PhD)

a. Department of Physiotherapy. University of Valencia. Valencia. Spain. b. Department of Physiotherapy. University of Seville. Seville. Spain. c. Madrid Osteopathic School. Madrid. Spain.

Received 16 February 2012 ; accepted 30 March 2012

ABSTRACT

Introduction: The tension-type headache is extremely common, and has repercussions in both the work environment and the social life of the people who suffer from them. Key Words: Objectives: To evaluate the efficiency of two treatments in patients with tension-type headaches. Tension-type Headache; Manipulation, Osteopathic; Material and Methods: A random, double-blind trial was Atlanto-occipital Joint undertaken, with seventy-six (n=76) patients (81.6% women) diagnosed with tension-type headache (39.9 ± 10.9 years), distributed in four groups (n=19 each one), three experimental groups and one control group (without intervention). Interventions in experimental groups included osteopathic manual therapy with: 1) Suboccipital soft tissue Inhibition Technique (SIT); 2) Occiput-Atlas-Axis global manipulation (OAA); 3) The combination of both (SIT+OAA). Treatments were applied during four sessions (one per week), with follow-up at 30 days. Patients were evaluated before and after treatment and during follow-up, by monitoring cervical mobility, the impact of and the frequency and intensity of the headache. Results: The SIT group significantly improved the impact of the pain (p=0.02). The OAA group and the SIT+OAA group, improved the headache impact and intensity (p<0.001 to p=0.05), and suboccipital flexion and extension (p<0.001 to p=0.04). The OAA group also improved cervical rotations (p=0.008 to p=0.007). The SIT+OAA group obtained significant results in the frequency and intensity of the pain (p<0.001 to p=0.05).

Conclusions: The three treatments applied were effective in the impact of headache and in pain

intensity. The OAA treatment is the most effective in increasing cervical mobility, followed by the SIT 0

treatment. The combined treatment SIT +OAA was the most effective in reducing the frequency and the 1

intensity of the pain caused by tension-type headache. age

P

* Corresponding author: email: [email protected] (Gemma Espí López) - ISSN on line: 2173-9242 © 2012 – Eur J Ost Clin Rel Res - All rights reserved - www.europeanjournalosteopathy.com - [email protected]

Espí-López GV, Oliva-Pascual-Vaca A.

INTRODUCTION and duration of the pain and the presence of active suboccipital trigger points. In 2004 the international headache society (IHS)1 carried out a classification of primary and secondary In a revision of the literature on the treatments for headaches, as well as their characteristics. According headaches, we have observed that the majority of the to Felício et al.2 between 22.65% and 30% of the studies applied a combination of procedures or soft population suffer from tension-type headaches (TTH), tissue techniques and manipulations,13-16 but were which have repercussions in the work and social unable to detect which of these was truly effective for environment, the daily life and the quality of life of those this pathology. For this reason we determined to test affected. the efficiency of manipulation of the occiput-atlas-axis (OAA) and suboccipital soft tissues inhibition technique TTH is the most common form of headache and a (SIT), separately and in combination (SIT + OAA). The health problem that has an important socio-economic objective of this study was to evaluate the efficacy of impact. Furthermore, tension-type headaches provoke the suboccipital inhibition technique (SIT) and occiput- a high number of visits to diverse health professionals atlas-axis manipulation (OAA) as treatments applied to and generate a large number of medical prescriptions alleviate pain, increase mobility and reduce the impact 3,4 5 with high associated costs . Stovner et al of pain in patients with TTH. Patients were further demonstrated that headaches occur during the most assessed one month after treatment ceased to productive ages, between 20 and 50 years, causing an determine whether the changes observed post- important reduction in the quality of life. Other treatment were maintained. studies6,7 showed similar clinico-epidemiological characteristics. MATERIAL AND METHODS

8 Couppe et al. measured the activity of the Design pericranial muscles using electromyography (EMG), after applying pressure to myofascial trigger points This was a randomized, placebo-controlled, double (TrP) in the neck and head, registering greater pain blind, factorial study, with four groups. According to intensity and frequency in patients with TTH compared the Nquery program, the necessary number of subjects to patients of the control group. According to Serrano et per group for an ANOVA of one inter-subjects factor al.9 contracture of the pericranial musculature and with four groups, assuming a significance level of 5% stress both play fundamental roles, participating in the for a high effect, is 19 subjects. The evaluations and mechanisms of central and peripheral sensitisation, that clinical interviews were performed by an evaluator who can account for the painful pericranial hypersensitivity had no knowledge of the studies objectives. All of the and a lowering of the pain threshold. Buchgreitz et al.10 patients (experimental and control groups) were maintain that central sensitisation caused by evaluated under the same conditions during all phases experiencing prolonged periods of pain can cause this of the study. to become chronic.

Study Population

Fernández et al.11 demonstrated the association 11 between trigger points in the trapezius muscles, the A total of 76 patients, who had been referred by sternocleidomastoids and the temporal muscles, in specialists from different fields, commenced the study patients with TTH with regard to the intensity and and all of them completed it. They were diagnosed with Page duration of the pain. In a later study, Fernández et al.12 frequent episodic TTH or chronic TTH. The other associated the cranio-cervical angle with the frequency

Eur J Ost Clin Rel Res. 2012;7(1):10-21.

Osteopathic Treatment of Tension-Type Headache

criteria for inclusion or exclusion are shown in Table 1. Experimental Group Interventions The study was carried out between January and We consider three experimental groups, each November 2010 at a specialised centre for headache integrated by 19 patients and defined as: Suboccipital treatment based in Valencia (Spain). Inhibition Technique group (SIT) received Suboccipital Inhibition Technique; Occiput-Atlas-Axis group (OAA) Randomization who received the Occiput-Atlas-Axis manipulation technique; combined group (SIT + OAA) received both Patients were randomly assigned to the interventions, Suboccipital Inhibition Technique and experimental or control group, which was double- also the Occiput-Atlas-Axis manipulation technique, in blinded (neither patients nor therapist knowing to which that order. During the treatment, four sessions were group they were assigned). The randomization was performed at seven day intervals. Each session had an performed with computer assistance by an assistant approximate estimated duration of 20 minutes. who had no relation to, nor knowledge of, the study or its objectives. Prior to the intervention, a bilateral vertebral artery test was performed on the patients of all groups Study Protocol (including the control). Following treatment, the patient remained in the rest position on the treatment table for The protocol was performed as follows: (1º) five minutes (10 minutes in the control group). Selection of the sample; (2º) Signature of informed consent;(3º) Randomization of patients to study - Suboccipital soft-tissue Inhibition technique (SIT). The groups;(4º) Preintervention assessments in the study application of this technique produces an inhibition of groups;(5º) Interventions in the study groups (SIT, OAA, suboccipital soft tissues. This tissue can respond to SIT+OAA, CONTROL - without intervention); (6º) local stimuli produced by tension and messages from Postintervention assessments in the study groups;(7º) higher control centres, that are probably activated by Statistical Analysis and interpretation of data obtained. pain or emotional stress16.

INCLUSION CRITERIA EXCLUSION CRITERIA

 Patients with infrequent episodic TTH and those patients  Be between 18 and 65 years of age with probable TTH in frequent and infrequent form.  Diagnosed with frequent episodic TTH and chronic TTH  Headache that is aggravated by head movements.  Have headaches on more than 1 day per month.  Metabolic disorders or musculoskeletal pathologies with  Suffer from episodes of pain lasting between 30 symptomatology similar to headache. minutes to 7 days  Previous neck trauma  Meet two of the following characteristics:  Vertigo, dizziness, arterial hyper/hypo tension ⁻ The pain is located bilaterally.  Joint stiffness, atherosclerosis or advanced osteoarthritis Pressing, non-pulsating pain. ⁻  Patients with cardiac devices ⁻ Suffer mild or moderate intensity pain.  Patients undergoing pharmacological adaptation ⁻ Headache is not aggravated by normal physical activity  Excessive emotional tension  May suffer from photophobia, phonophobia, nausea or  Neurological alterations vomiting  Laxity of the cervical soft tissue  The headache may be associated with pericranial

12  Radiological alterations tenderness  Suffer TTH for more than three months  Generalised hypermobility or hyperlaxity  Be under pharmaceutical control  Articular instability

Page  Pregnancy

Table 1. Criteria for inclusion in this clinical study. TTH Tension-type headache; Episodic TTH; Chronic TTH.

Eur J Ost Clin Rel Res. 2012;7(1):10-21.

Espí-López GV, Oliva-Pascual-Vaca A.

To perform the technique we use palpation of the The rest position is the same for all groups, with suboccipital musculature to locate the posterior arch of the patient adopting the supine resting position, in the atlas. A deep, progressive, sliding pressure is neutral ranges of cervical flexion, extension, rotation applied. The objective is to release the spasms in the and inclination. This allows the tissues to adapt to the occipital muscles and soft tissues that provoke joint changes they might have undergone, as well as to any dysfunction in the occiput, atlas and also the axis. temporary vasospasm that could have been produced following manipulation. Furthermore, this position The therapist sits at the head of the patient, placing produces a general relaxation of the cervical and their hands so that the occiput rests in the palms of the suboccipital areas, eliminating the compression effects hands. With the hands in the correct position, upward caused by gravity. pressure is applied to the atlas, the occiput being supported by the hands while the atlas is suspended by Control Group Intervention the finger tips. The pressure should be maintained for

various minutes18-20. We do not apply any technique to the control group, but patients in the control group received the - Occiput-Atlas-Axis global manipulation (OAA). This same assessments (impact of headache, goniometry, technique, first described by Fryette21, has been used in records), and the rest position was higher (10 minutes). other trials22. It is employed to increase the range of Assessments were performed before the first session, motion of the between the occiput-atlas-axis, at end of treatment and the follow-up at 30 days, as for permitting the correction of a global dysfunction. It is a all groups. structural technique, applied bilaterally through a vertical line that passes through the odontoid apophysis Assessments and Variables

of the axis, which uses neither flexion nor extension, and very little lateroflexión19 Following assignment to the corresponding group, individual clinical interviews were conducted that The osteopath stands on the side to be included the collection of socio-demographic data. manipulated, their centre of gravity situated vertical to the area to be treated. The superior hand supports the Subsequently, the evaluations described as follows head; the forearm is situated on the axis of the odontoid were performed during three stages of the trial: at the apophysis, and the head is then placed in right rotation. beginning, at the end of the four week treatment period The inferior hand controls the opposing side of the and at follow-up, 30 days after the end of treatment. head, on the side to be manipulated; the thumb rests behind the mastoid, the index finger rests over the - Impact of Headache. The impact of headache using temple, and the second finger rests in the direction of the Impact Ttest-6 (HIT-6) questionnaire, published by the internal angle of the eye. The ring finger, in Ware et al.23 evaluates the impact that headache has metacarpalphalangeal flexion with phalanges 2ª and 3ª on the patient’s work or daily activities. It demonstrates in extension, is placed below the chin. The forearm the effect that headaches have on a patient’s normal rests on the sternum of the patient with the elbow daily life and their capacity to function. For the scoring

pointing toward the feet. The barrier to motion is located interpretation of the Spanish version of HIT-624 the 13 applying selective tension, and a high velocity replies are classified: never (0 points), almost never (5

manipulation is performed in pure rotation toward the points), occasionally (10 points), frequently (15 points) Page side being manipulated without raising the head. and always (20 points). For a total of 48 points or less there is no functional limitation, between 50 and 60

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Osteopathic Treatment of Tension-Type Headache

points a visit to the doctor is recommended, between 50 Descriptive analysis of the sample in general and by and 54 there is some impact, between 55 and 68 the groups was performed for absolute and relative impact is moderate and for a score of over 60 the frequencies, mean scores, standard deviation and the confidence interval. An ANOVA was performed during impact is severe. the pretest to confirm the homogeneity of the groups prior to starting treatment. This included the calculation - Cervical Mobility. Assessment of cervical segment and interpretation of the partial eta squared for the mobility using the CROM goniometer. This is an easy- effect size index. In ANOVA-type analyses Levene's to-use, low cost evaluation method. The cervical range statistic is calculated to confirm the assumption about of motion (CROM) (Performance Attainment Associates. the homogeneity of variance. In those cases where the 958 Lydia Drive, Roseville, Minnesota, USA. 55113) result was significant, the Welch, and Brown-Forsythe combines a system of inclinometers and magnets robust F tests were performed. arranged on a mainframe headpiece with a support to Likewise, the t-test for dependent samples was the bridge of the nose, that measures the degree of performed to compare the means of the pretest and movement in flexion, extension, inclination and rotation. post-test and of the pretest and the follow-up It also permits measurement of the range of movement (separately for each one of the groups) and for the of the suboccipital spine (C0-C1-C2). Different trials25-28 calculation and interpretation of the standardised mean have demonstrated the reliability of the instrument. In change effect size. The Kolmogorov-Smirnov test was this trial we evaluated cervical movements of flexion used in the t-tests separately, for each group, and each and cervical and suboccipital extension, in addition to measurement, in order to confirm compliance with the both rotations, with the aim of evaluating the possible assumption of normality. When this was not observed, limitation of mobility that might be suffered by patients the means were compared using the Wilcoxon signed- with TTH. We had to bear in mind that this instrument rank test. In order to check the association between incorporates a system of magnets and should not qualitative variables the 2 test was applied, and for therefore be used on subjects fitted with devices such global associations in the ordinal variables the gamma as pacemakers or defibrillators. coefficient () was used. The established level of significance in all the analyses was 5%. With regard to Prior to the trial, a pilot study was undertaken with the effect size: 0.2-0.5 was considered small two experienced evaluators and 12 subjects, who were magnitude, 0.5-0.8 medium magnitude and >0.8 large evaluated for the range of mobility in suboccipital magnitude.

flexion and extension and the cervical spine's global range of motion, in addition to rotation to both sides. RESULTS The global correlation between both evaluators in this trial was 0.98. The means obtained for the evaluators Of the 76 subjects in the sample, 62 were women were 44.79 and 44.92 respectively. (81.6%) and 14 were men (18.4%). The average age was 39.96 years (SD=10.93), ranging between 18 and - Frequency and Intensity of the pain. To evaluate 65 years. The time of evolution of the TTH for the whole the frequency and intensity of the pain we employed an sample varied from 1 to 53 years, with a mean of 10.98 easy to use daily register of scale - the visual analogue (SD=11.78). scale (VAS) - that can be analogical or visual and refers

to the intensity of the pain felt by the patient at the time The patients feel pain in different areas of the

of the test. head: 36.8% feel pain in the occipital zone, 34.2% in 14 the interparietal zone and 29% in the frontotemporal Statistical Analysis zone. The moment of pain onset was variable: in 18.4% Page of the patients the headache began first thing in the The data was codified and analyzed using the morning, while in 44.7% of the patients the pain started statistics program SPSS for Windows (version 15.0).

Eur J Ost Clin Rel Res. 2012;7(1):10-21.

Espí-López GV, Oliva-Pascual-Vaca A. at any time during the day. For 6.7% headache onset free time activities (FTA) and by 64.2% engaged in was late in the day and 30.3% reported no fixed time for work-related activities. onset, with this being variable from day to day. On average the duration of the pain episodes was 1.43 With respect to the impact of the headache as days (SD=0.77). evaluated with the HIT-6 questionnaire, the OAA group and the SIT + OAA group showed significant 100% of the patients suffered from bilateral pain. differences after treatment and in the follow-up with a The patients reported a non-pulsatile pain in 81.6% of large effect size. the cases and pulsatile in the remainder of the sample (18.4%); some 92.1% of the patients reported having In cervical mobility the results showed that medium intensity pain and 7.9% moderate pain. In suboccipital flexion obtained significant results in all of 69.7% of the patients pain did not increase with the experimental groups and in all the evaluations; physical activity; some 40.8% reported that they suboccipital extension improved in the groups with a suffered pain on more than 15 days a month, whilst the manipulation component (OAA and SIT+ OAA), with a rest said they had pain for less than 15 days. greater effect size noted in the SIT+OAA group. Results for craniocervical flexion were positive in the SIT group With respect to the severity of the headache in the with medium and large effect size, although this also previous month, 50 patients (65.8%) suffered occurred in the control group but with a smaller effect headaches of moderate intensity, 17 patients (22.4%) size. perceived them as severe and 9 patients (11.8%) as mild. Regarding the pain intensity, measured using the Craniocervical extension improved in the Visual Analogue Scale (VAS), the mean was situated at manipulation group in both evaluations. The range of 6.58 (SD=1.73). A total of 42.1% of the patients have rotation to both sides improved significantly in both direct family members who experience headache. evaluations in the articulatory group. All the results relating to mobility are shown in Table 3. 51.3% of the patients reported that the pain was triggered by physical effort or by drinking alcohol, either In the register, the frequency of headache was together or in isolation. In 34.2% of the patients the pain statistically significant in the SIT+OAA group and the was triggered by ingesting certain foods, such as intensity improved in the follow-up for all groups, but chocolate, cheese or coffee. had a larger effect size in the experimental groups (SIT, OAA, SIT+OAA) (Table 4). As an aggravating factor, stress was considered to be the most important by 69.7% of the patients. In DISCUSSION addition, job related factors aggravated the pain in 52.6% of the sample, whilst emotional, family and study-related factors affected 19.7%, 19% and 7.9% of In our study the results confirm that TTH has the total sample respectively. specific pain characteristics that coincide with the IHS1

classification as well as in aspects that influence TTH

Depending on the activity to be performed, the such as trigger and aggravating factors and having a 15 impact of the pain was different: It was considered family history of tension-type headaches29. The majority moderate by 72.4% of patients during the activities of of sufferers are women, which coincides with all of the daily living (ADL), by 61,8% during moderate-intensity studies that were revised.30,31 As with other studies, we Page

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Osteopathic Treatment of Tension-Type Headache

VARIABLE STUDY GROUP

HIT-6 SIT OAA SIT + OAA CONTROL

Pre-treatment 59,21 (9,01) 60,32 (6,29) 60,68 (7,993) 58,11 (6,56) Post-treatment 57,58 (7,87) 53,74 (6,19) 56,11 (8,432) 55,21 (7,85) Follow-up 55,05 (7,42) 53,11 (6,33) 53,26 (7,362) 55,63 (8,05) Pre-Post Treatment t=0,88;p=0,39 t=3,98;p=0,001* z=-1,99;p=0,04* z=-2,247;p=0,02* Effect size 0,18 1,00 0,55 0,42 Pre Follow-up t=2,53;p=0,02* t=5,47;p=0,000* z=-2,92;p=0,003* z=-1,5;p=0,13 Effect size 0,45 1,09 0,89 0,36

Table 2. Results of the impact of pain with HIT-6 questionnaire The results are presented with the mean and standard deviation (SD); z Wilcoxon; t Student; * p ≤ 0.05

have included patients with episodic and chronic TTH. studies,29,38 the incidence of bilateral pain had a lower Other studies were restricted to patients with episodic percentage. TTH,29,36 whilst other authors only included patients suffering from chronic TTH.37 In contrast, with respect to the classification of the perceived severity of the pain (mild, moderate, severe), The pain, whilst characterised as covering all of the moderate was the answer given by the majority of the head like a "helmet," is localised principally in the subjects of our study sample, which is similar to other occipital and interparietal zones and to a lesser extent studies38. in the frontal zone. In the study performed by Silberstein et al.38.patients suffered from pain in the In the patients of our study, the pain became frontal region (95%), in the occipital zone (53%), in the established in a variety of ways. This can be explained interparietal zone (33.6%), and from pain throughout because it is the triggers, the aggravating factors and the head like a helmet (25.6%). The patients also the situations of stress, and tension, produced during reported one or more areas of pain. In our study we the course of daily life that provoke the headache. The have analyzed the predominance of greater intensity, associated symptoms are in the majority photophobia given that in tension-type headache pain is felt or phonophobia, pericranial tenderness and, to a lesser throughout the head with predominance in one extent, nausea or vomiting. Other authors38,39 obtained particular zone, it being sometimes difficult to determine similar results in relation to these symptoms. which area is the most painful. More than half the sample subjects have a direct According to the IHS1, TTH must present with two family history of primary headaches. In the study by or more of the following characteristics: it must be Matta and Moreira29, the family history of headache was bilateral, with non-pulsatile pressure; the headache 24% in a sample of 50 subjects, whilst in Holroyd et al.

must not increase during physical activity and should be 33 it was 67% in a sample of 245 patients. The average

of medium to moderate severity. The majority of the age of the patients (39.7) usually coincides with the

16

subjects of our study reported suffering from a bilateral peak of commitments to work and family, resulting in

pain and the greater part also reported that the greater stress due to the increased demands of both Page headache was not pulsatile and that once established it environments. did not increase during physical activity. In other

Eur J Ost Clin Rel Res. 2012;7(1):10-21.

Espí-López GV, Oliva-Pascual-Vaca A.

VARIABLE STUDY GROUP SIT OAA SIT + OAA CONTROL Suboccipital Flexion Pre-treatment 8,53 (5,12) 9,11 (3,48) 6,58 (2,27) 8,42 (4,75) Post-treatment 12,68 (4,70) 15,26 (4,85) 11,47 (4,78) 9,68 (4,33) Follow-up 12,11 (5,40) 12,00 (5,18) 10,89 (4,75) 9,32 (3,98) Pre-Post Treatment z=-2,41; p=0,01* z=-3,63 ;p=0,000* z=-3,14 ;p=0,002* z=-1,39 ;p=0,16 Effect size 0,77 1,69 2,06 0,25 Pre Follow-up z=-1,92; p=0,05* z=-2,74 ;p=0,006* z=-2,85 ;p=0,004* z=-0,59 ;p=0,55 Effect size 0,67 0,79 1,82 0,18 Suboccipital Extension Pre-treatment 17,11 (10,33) 17,32 (9,92) 13,42 (7,14) 12,42 (6,38) Post-treatment 17,37 (7,60) 23,53 (9,67) 19,84 (10,31) 14,74 (6,32) Follow-up 19,32 (12,55) 21,26 (10,27) 20,11 (12,21) 12,16 (5,33) Pre-Post Treatment z=-0,58 ;p=0,56 z=-2,86 ;p=0,004* z=-3,68 ;p=0,000* z=-2,71 ;p=0,007* Effect size 0,02 0,60 0,86 0,34 Pre Follow-up z=-0,28 ;p=0,77 z=-2,09 ;p=0,04* z=-2,86 ;p=0,004* z=-0,36 ;p=0,72 Effect size 0,20 0,38 0,90 0,04 Cervical Flexion Pre-treatment 49,26 (12,88) 52,42 (10,23) 52,89 (12,63) 50,63 (11,34) Post-treatment 60,26 (11,78) 54,68 (10,06) 53,74 (11,11) 54,99 (11,02) Follow-up 56,68 (11,13) 51,37 (10,73) 53,00 (10,54) 52,74 (10,58) Pre-Post Treatment z=-2,96 ;p=0,003* z=-1,69 ;p=0,09 z=-0,91 ;p=0,36 z=-2,36 ;p=0,02* Effect size 0,82 0,21 0,06 0,36 Pre Follow-up z=-2,07 ;p=0,04* z=-0,50 ;p=0,62 z=-0,60 ;p=0,55 z=-2,03 ;p=0,04* Effect size 0,55 0,09 0,01 0,18 Cervical Extension Pre-treatment 51,89 (14,19) 48,16 (10,33) 53,16 (13,37) 51,32 (11,28) Post-treatment 57,84 (13,20) 56,16 (12,15) 58,21 (14,80) 53,89 (11,26) Follow-up 55,00 (12,68) 53,68 (7,72) 58,58 (11,32) 54,42 (11,64) Pre-Post Treatment t=-2,15 ;p=0,04* t=-2,41 ;p=0,03* t=-2,209 ;p=0,04* t=-1,47 ;p=0,16 Effect size 0,40 0,74 0,36 0,22 Pre Follow-up t=-0,85 ;p=0,41 t=-2,16 ;p=0,04* t=-1,72 ;p=0,10 t=-1,79 ;p=0,09 Effect size 0,21 0,51 0,39 0,26 Right Rotation Pre-treatment 60,63 (11,74) 60,26 (8,35) 62,47 (9,61) 58,26 (10,08) Post-treatment 65,00 (12,26) 69,05 (7,91) 67,58 (10,09) 61,53 (7,84) Follow-up 61,16 (12,22) 66,79 (7,56) 65,58 (10,93) 60,47 (8,08) Pre-Post Treatment z=-2,23 ;p=0,03* z=-3,34 ;p=0,001* z=-2,02 ;p=0,04* z=-1,77 ;p=0,07 Effect size 0,36 1,00 0,51 0,31 Pre Follow-up z=-0,33 ;p=0,74 z=-2,65 ;p=0,008* z=-1,55 ;p=0,12 z=-0,28 ;p=0,78 Effect size 0,04 0,75 0,31 0,21 Left Rotation Pre-treatment 56,95 (14,59) 64,11 (8,53) 62,84 (11,24) 62,21 (9,87) Post-treatment 64,11 (13,84) 71,84 (7,67) 67,74 (12,34) 63,47 (10,19) Follow-up 62,58 (10,77) 69,16 (8,30) 66,37 (11,92) 61,47 (10,00) Pre-Post Treatment t=-4,1 ;p=0,001* t=-3,02 ;p=0,007* t=-2,42 ;p=0,03* t=-0,98 ;p=0,34

Effect size 0,47 0,87 0,42 0,12 Pre Follow-up t=-2,27 ;p=0,04* t=-3,02 ;p=0,007* t=-1,52 ;p=0,14 t=0,79 ;p=0,44

Effect size 0,37 0,57 0,30 0,07

17

Table 3. Results of the range of cervical mobility. Page The results are presented with the mean and standard deviation (SD); z Wilcoxon; t Student; * p ≤ 0.05

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Osteopathic Treatment of Tension-Type Headache

VARIABLE STUDY GROUP Weekly Register SIT OAA SIT + OAA CONTROL Frecuency Week 1 3,16 (2,32) 2,74 (1,82) 3,74 (1,82) 3,11 (1,52) Week 4 2,58 (2,19) 1,53 (1,90) 1,47 (1,50) 2,53 (1,50) Week 7 3,32 (2,06) 2,05 (2,27) 1,37 (1,26) 2,89 (1,97) Week 1-4 t/z t=1,45; p=0,16 z=-2,56; p=0,01* z=-3,53; p=0,000* t=1,64; p=0,12 Effect size 0,24 0,64 1,19 0,36 Week 1-7 t/z t=1,60; p=0,13 z=-1,34; p=0,18 z=-3,16; p=0,002* t=0,44; p=0,66 Effect size 0,07 0,36 1,25 0,14 Intensity Week 1 4,80 (2,32) 5,06 (2,00) 4,72 (1,69) 5,22 (1,86) Week 4 3,66 (2,53) 2,90 (2,81) 3,25 (2,80) 4,05 (2,13) Week 7 2,70 (2,20) 3,14 (2,37) 2,87 (2,57) 3,88 (2,06) Week 1-4 t/z t=1,62; p=0,12 t=2,60; p=0,02* z=-1,98; p=0,05* t=2,14 ; p=0,05* Effect size 0,47 1,03 0,83 0,60 Week 1-7 t/z t=2,43; p=0,03* t=2,79; p=0,01* z=-2,42; p=0,02* t=2,17 ; p=0,04* Effect size 0,87 0,92 1,05 0,69

Table 4. Results of the register of headache with respect to frequency and intensity The results are presented with the mean and standard deviation (SD); z Wilcoxon; t Student; * p ≤ 0.05

The pain intensity measured using VAS gave a experimental groups showed significant improvements result of 6.58. Other studies32,40 coincided in the in the impact of pain, but the control did not. The average severity of pain suffered by the majority of TTH greatest effect size was for the OAA and the combined patients, according to the IHS1. The pain triggers, (SIT+OAA) group. The range of craniocervical mobility either together or in isolation, are found in a majority of was evaluated using the CROM goniometer. Since this patients and are: coughing, nose blowing, physical can be regarded as a situational test, subject to effort, and the ingestion of alcohol, chocolate, coffee or different interpretations on the part of the evaluator, a cheese. Stress is the most important aggravating factor, reliability study between the two evaluators was carried followed by job related, emotional and family factors - out prior to the start of the study and gave a Pearson these being similar to other studies33. The evolution correlation of 0.98. Other authors41 obtained reliabilities time of the headaches varied from 1 to 53 years, with a between 0.61 and 0.97. In this study we have included mean of 10.98 years (SD=11.78), signifying that in the evaluation of the two movements of suboccipital some cases subjects suffer from TTH almost all their flexion and excluded the movement of inclination, since life. In other studies, such as Straube et al.39, and this was not an objective of the treatments used. In Melchart et al.34, the average is still higher, being 13 suboccipital flexion following treatment and in the and 14.5 years respectively. The results of our study on follow-up, all the experimental groups improved

the impact of pain showed an average score of 59.21 at significantly, but the control group did not. Suboccipital

the beginning and 55.58 after the treatment; the extension improved significantly following treatment and 18 majority of subjects presenting with a severe at follow-up in the OAA group and SIT+OAA group.

condition. By groups, the patients receiving OAA, the The control showed significant differences following Page combined treatment (SIT+OAA) and the control had all treatment, but these were not found at the follow-up. improved, however at 30 days post treatment the three

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Espí-López GV, Oliva-Pascual-Vaca A.

With respect to cervical flexion, the SIT group and The effectiveness of manipulation in the treatment the control group improved following the treatment and of TTH was shown to be positive in our study, obtaining at follow-up, however the effect size in the control group significant results in the majority of the evaluations was small. The cervical extension obtained performed, both at post-treatment and at follow-up. improvements in the three experimental groups Other studies45,46 have not found conclusive results for following the treatment, but this was only maintained in the effectiveness of vertebral manipulation, probably the OAA group. Mobility in right rotation improved because they did not include a control, or were significantly after treatment in all experimental groups performing single blind-control studies. In our study we but was only maintained in the OAA group and with a have manipulated one vertebral segment and obtained large effect size. For the left rotation, the three better results, not only in frequency and intensity, but experimental groups improved significantly following also in the impact of the pain and suboccipital mobility. treatment and these improvements were maintained in Other authors applied the combination of various the SIT group and the OAA group. Our results techniques, obtaining significant results in the intensity demonstrate that for the two evaluations performed, the of the pain, the range of cervical mobility42 and in the OAA treatment was the most efficient in improving frequency16 however, given that this consisted in the cervical mobility (post-treatment and follow-up). This application of various combined techniques, we cannot improvement was observed in 5 of the 6 movements know which of these was the most effective. The evaluated. The greater efficiency of the OAA treatments employed in this study require an manipulation treatment with regard to cervical mobility experienced therapist, due to the precision and might be because it involves the application of a complexity of the techniques applied and because of technique in bilateral suboccipital rotation, which may the need to understand headache progression. In our have a relaxant effect in this region, thereby facilitating study the techniques used have been performed by movement at this level. Knutson et al. 42,43 highlight the therapists with more than 10 years’ experience in the existence of a component of immediate, post- application of osteopathic treatments for primary manipulation relaxation, resulting from the momentary headaches. reduction in muscle tone, however in our study this improvement was not only produced following The results found in this study indicate that both treatment, but was maintained at the 30 day follow-up. patients who suffer from TTH, and the professionals In our study we have evaluated each cervical who treat this pathology, will be able to benefit from movement separately, whilst other authors44 have them, since they bring together various aspects measured ranges: flexion and extension, right/left implicated in the understanding and treatment of the inclination and both rotations. We consider the tension-type headache and provide new perspectives separate measurement of each movement to be more for future research, using other treatments and for other informative. The SIT was effective in suboccipital and types of primary headaches. cervical flexion and in left rotation. This might be because the application of this technique causes the Study Limitations relaxation of the posterior suboccipital muscles that Notwithstanding the results for the combined participate in the extension and rotations of the first

treatment, nor the fact that the combination of the two 19

cervical vertebrae, which may have helped increase the techniques in our study has proved to be effective in the flexion. For the control group, there was an areas assessed, we nonetheless question whether improvement in cervical flexion in both groups, however Page changing the order16 of the techniques (OAA followed this was obtained with a small effect size. by inhibition) would have been more effective.

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Osteopathic Treatment of Tension-Type Headache

Compared with the other treatments used, we have their informed consent and all of the procedures were obtained fewer significant results with the suboccipital performed in accordance with the Helsinki49 declaration.

soft tissue inhibition technique, this showing itself to be CONFLICT OF INTEREST the least effective treatment; probably due to the The authors of the manuscript declare no conflict of application procedure that produced no tissue interest. displacement, and was not combined with other techniques47, and might therefore resemble a placebo ACKNOWLEDGMENTS treatment. The application of soft tissue techniques has The authors thank the participants in this study for an relaxant effect on the cervical musculature, reducing their generous collaboration. both pain frequency and intensity15,48 but in our study we have not considered specific trigger points. If they REFERENCES

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